The Creating Hope Act pediatric priority review voucher program has been wildly successful. It is critical that Congress reauthorize the program permanently so that children with serious illnesses can have hope for new therapies, better health and even possibly cures.
The Creating Hope Act establishes an incentive for drugs to be developed expressly for children with rare diseases. The incentive is a priority review voucher that can be earned by a company that develops a rare pediatric disease drug. The vouchers come with rights to faster FDA review of any other drug, including a drug that would not be for any rare pediatric diseases.
Since the passage of the Creating Hope Act pediatric priority review voucher program, the FDA has approved 19 new therapies for children with serious illnesses, two of which are for children with cancer.
Vouchers have traded for as much as $350 million, providing a significant incentive for drug development for seriously ill children. $2 billion in vouchers have been traded.
The Creating Hope Act has helped children like Emma Whitehead, who was treated with the first FDA approved drug for a gene therapy, Novartis’ Kymriah, for B-cell precursor ALL. Kyrmiah earned a voucher. In addition, Y-mABs Therapeutics is using the pediatric priority review voucher program to develop exciting new therapies for children with neuroblastoma and other pediatric cancers.
Now is the time for the Creating Hope Act to be permanently reauthorized. There is clear evidence of its impact. There are 370 days before the Creating Hope Act expires. On this fourth reauthorization, we are asking for permanency. Congress has passed two other voucher programs based on the provisions of the Creating Hope Act — for tropical diseases and medical countermeasures. Both of these voucher programs are permanent while the Creating Hope Act is not. Now is the time we make this permanent for our children!
The Creating Hope Act Authorization has been endorsed by the following organizations: 3/32 Foundation, Adam’s Angels Ministry, Alex’s Army Childhood Cancer Foundation, Amanda Riley Foundation, Association of Pediatric Hematology Oncology Nurses, Braden’s Hope For Childhood Cancer, Bridge the Gap – SYNGAP Education and Research Foundation, Brooke’s Blossoming Hope for Childhood Cancer, Brown University/Hasbro Children’s Hospital, Caleb’s Crusade for Childhood Cancer, Cancer Care Manitoba, Cancer Free KIDS, Carson Leslie Foundation, CHEMOWARRIOR: the Eli Sidler Foundation, Children’s Hospital of Philadelphia, Chloe’s Journey of Faith Foundation, Christina Renna Foundation Inc., Circle of Care, Conner Cares, Curtana Pharmaceuticals, DADA2 Foundation, Daniel’s House Publications, DBSA, EveryLife Foundation for Rare Diseases, FFAME (Family, Friends and Allies of ME/cfs, Foster Tree Service, Gabriella’s Smile Foundation, Georgetown Lombardi Comprehensive Cancer Center, GIC Group/Global Food Safety Forum, Gold Rush Cure Foundation, Grace Way Foundation, Grandparents in Action, Harvard Medical School/ Massachusetts General Hospital, International Society of Paediatric Oncology (SIOP), Jack’s Angels, Jeffrey’s Voice, Joey’s Wings Foundation, Jonah’s Just Begun, Julia’s Grace Foundation, Kids vs Cancer, Kids Without Cancer, Kier’s Kidz, Lucy’s Love Bus, Mackey Children’s Cancer Foundation, MIB Agents, Michael Mosier Defeat DIPG Foundation, NanoValent Pharmaceuticals, National MPS Society, National Organization for Rare Disorders® (NORD), NF2 BioSolutions, Noah’s Bandage Project, Noah’s Hope, Oral Health Nursing Education and Practice, Pediatric Assessment, Learning & Support, Pediatric Cancer Foundation, Pediatric Valley Medical Center, Perlmutter Cancer Center at NYU Langone Health, Rally Foundation for Childhood Cancer Research, Rett’s Roost, Sadie Keller Foundation, Samuel Jeffers Childhood Cancer Foundation Section 32, St. Jude Children’s Research Hospital, Stephen T Marchello Scholarship Foundation, Super Sam Foundation, Swifty Foundation, Syndax Pharmaceuticals, Team G Childhood Cancer Foundation, Teen Cancer America, The Cooper Max Foundation, The Cure Starts Now North Texas, The Dandy Horse, Inc., The Jesse Heikkila Foundation, The Maeve McNicholas Memorial Foundation, The National Children’s Cancer Society, The Nicholas Conor Institute, The Progeria Research Foundation, The Rare Childhood Cancer Advocacy Group, The Scott Carter Foundation, The Steven G AYA Cancer Research Fund, The Valerie Fund, This Star Won’t Go Out, Toby Knapp Radio, Wade’s Army, We Believe Foundation, Wylie’s Day Foundation, Y-mAbs Therapeutics Inc., Biotechnology Innovation Organization
George “G.K.” Butterfield Jr.Representative for North Carolina’s 1st congressional district, introduced HR. 4439 on September 20, 2019
HR. 4439 has 11 cosponsors (6R, 5D)
This is the action you can take to get this bill sent to the floor of the House for a vote:
Tweet and/or call members of the Energy and Commerce Committee in order to get this bill sent to the House for a vote. Use sample below for your request:
Please approve HR. 4439, The Creating Hope Act Authorization in order to provide incentives for drug development for children with rare diseases.
|Bilirakis, Gus M.||FL||12th||@RepGusBilirakis||(202)||225-5755|
|Blunt Rochester, Lisa||DE||At Large||@RepLBR||(202)||225-4165|
|Brooks, Susan W.||IN||5th||@SusanWBrooks||(202)||225-2276|
|Burgess, Michael C.||TX||26th||@MichaelCBurgess||(202)||225-7772|
|Butterfield, G. K.||NC||1st||@GKButterfield||(202)||225-3101|
|Carter, Earl L. “Buddy”||GA||1st||@RepBuddyCarter||(202)||225-5831|
|Clarke, Yvette D.||NY||9th||@YvetteClarke||(202)||225-6231|
|Doyle, Michael F.||PA||18th||@USRepMikeDoyle||(202)||225-2135|
|Engel, Eliot L.||NY||16th||@RepEliotEngel||(202)||225-2464|
|Eshoo, Anna G.||CA||18th||@RepAnnaEshoo||(202)||225-8104|
|Gianforte, Greg||MT||At Large||@GregForMontana||(202)||225-3211|
|Griffith, H. Morgan||VA||9th||
|Kelly, Robin L.||IL||2d||@RobinLynneKelly||(202)||225-0773|
|Kennedy, Joseph P., III||MA||4th||@RepJoeKennedy||(202)||225-5931|
|Kuster, Ann M.||NH||2d||@AnnMcLaneKuster||(202)||225-5206|
|Latta, Robert E.||OH||5th||@BobLatta||(202)||225-6405|
|Lujan, Ben Ray||NM||3d||@RepBenrayLujan||(202)||225-6316|
|Matsui, Doris O.||CA||6th||@DorisMatsui||(202)||225-7163|
|McEachin, A. Donald||VA||4th||@RepMcEachin||(202)||225-6365|
|McKinley, David B.||WV||1st||@RepMcKinley||(202)||225-4172|
|McMorris Rodgers, Cathy||WA||5th||@CathyMcMorris||(202)||225-2006|
|Peters, Scott H.||CA||52d||@RepScottPeters||(202)||225-0508|
|Rush, Bobby L.||IL||1st||@RepBobbyRush||(202)||225-4372|
|Sarbanes, John P.||MD||3d||@RepSarbanes||(202)||225-4016|
|Schakowsky, Janice D.||IL||9th||@JanSchakowsky||(202)||225-2111|
|Veasey, Marc A.||TX||33d||@MarcVeasey||(202)||225-9897|
|Welch, Peter||VT||At Large||@PeterWelch||(202)||225-4115|
|Pallone, Frank, Jr.||NJ||6th||@FrankPallone||(202)||225-4671|